"Due to the elevated markers, the prolonged procedure time and the increased volume of contrast used, it is probably wise to use the simpler strategy. It's not prohibitive to take the complex approach however, because both procedures had the same, excellent clinical outcome."

By The American College of Cardiology, [RxPG] Cardiologists increasingly use non-invasive methods to treat patients with diseased arteries that previously required open-heart surgery. A late-breaking clinical trial presented today during the American College of Cardiology's inaugural Innovation in Intervention: the i2 Summit 2006. Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.

When both a main artery in the heart and a smaller branch connected to it are narrowed by coronary artery disease, repairing the damage with the use of multiple stents (small, lattice-shaped, metal tubes inserted permanently into an artery) is technically challenging. Further, this type of coronary artery disease called a "bifurcation lesion" is prone to re-narrowing or blocking again after treatment. The use of drug-eluting stents coated with medicine to keep the artery from re-narrowing has improved the outcome of this kind of procedure, but the optimal method to treat bifurcation lesions has not been established.

This study examined two ways of treating severe diseased arteries: by placing stents in both the main artery and the side branch or by stenting the main artery alone with the option of stenting the side branch. Researchers looked at major adverse coronary events (MACE  if some of the patients died, suffered from a heart attack, needed re-treatment or had a clogging of the artery) to determine which strategy would provide the best outcome.

A total of 413 patients with extensive cardiac artery disease were randomized in a multi-center study conducted by the Nordic PCI Study Group. The patients were randomized in two groups: one treated with drug-eluting stent in both the main vessel and the side branch (206 patients), the other group treated with drug-eluting stent only in the main vessel (207 patients). The treatment was successful in nearly 100 percent of patients. Only 4.3 percent of patients in the group originally scheduled for stenting in only the main branch ultimately received stents in both branches. This is a very low rate of crossover, according to presenting author Terje K. Steigen, M.D., Ph.D., contributing to more reliable findings.

At six months, clinical results show that patients in both groups had similar positive outcomes and very low rates of complications  less than 5 percent in both groups experienced MACE. The patients who were stented in both the main artery and the side branch  the more complex procedure of the two  experienced a longer time in the cardiac catheterization lab with more exposure to X-rays and contrast medium necessary to complete the procedure. These patients showed increased rates in procedure-related biochemical marker release, a blood test that indicates injury to the heart muscle. While eight percent of patients who underwent the simpler procedure showed significant biochemical marker release, 18 percent of those in the more complex procedure group showed significant biochemical marker release.

"Since the clinical results are equally good in both groups, you have to look at the advantages of one technique over the other," said Dr. Steigen, of University Hospital of Northern Norway, Tromsoe. "Due to the elevated markers, the prolonged procedure time and the increased volume of contrast used, it is probably wise to use the simpler strategy. It's not prohibitive to take the complex approach however, because both procedures had the same, excellent clinical outcome."

Publication:
Dr. Steigen will present the results of the "Main Vessel and Side Branch Stenting versus Optional Side Branch Stenting Using Sirolimus-Eluting Stents in Bifurcation Lesions" on Monday, March 13 at 9:45 a.m.
On the web:www.acc.org

The American College of Cardiology (www.acc.org) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and the ACC inaugural i2 Summit, the first-ever meeting for interventional cardiologists, will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.

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